Skip to main content
Loading Events

« All Events

Clinical Protocol Development Series

October 26 @ 9:00 am - 11:00 am

The goal of this two-day series is to provide researchers with knowledge, tools, and resources to aid in the development of a scientific protocol for a clinical research study. Both sessions will begin at 9:00 AM and a question-and-answer session will follow each presentation. The first day of the series will provide an introduction and a review of research support/resources. The second day will take focus more on clinical study design, statistics, and their impact on clinicaltrials.gov reporting.

Registration is open for the 2021 Clinical Protocol Development Series. This series is aimed at academic researchers, scientists, study coordinators, and students engaged in clinical research and/or clinical trials.

The goal of this two-day series is to provide researchers with knowledge, tools, and resources to aid in the development of a scientific protocol for a clinical research study. Both sessions will begin at 9:00 AM and a question-and-answer session will follow each presentation.

The first day of the series will provide an introduction and focus on the following key points:
– Who needs a clinical protocol and why it is important
– Types of clinical protocols, and content expectations for sections of the protocol
– Introduction to clincaltrials.gov
– UNC Scientific Review processes
– Protocol problems spots and ways to improve protocols
– Resources and tools available at UNC to support clinical protocol development

On the second day of the series we will take a “deeper dive” into clinical study design, statistics, and their impact on clinicaltrials.gov reporting:
– Clinical Protocol Study Design – aims, objectives, endpoints, and outcomes
– Statistical Analysis, sample size considerations, data management
– Clinicaltrials.gov – outcome measure reporting
– Protocol problem spots and ways to improve protocols

ACRP Contact Hours: 4.0 Contact Hours of clinical research education on the application for maintenance of ACRP’s ccrc®, ccra® or cpi®, certification designations will be available for attendees

Through the UNC Event Registration system, you can sign up to attend one session or both. 

Details

Date:
October 26
Time:
9:00 am - 11:00 am
View Event Website

Other

Contact Email/Phone
marie_rape@med.unc.edu